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Transparency in research challenged by judicial review

Transparency in research challenged by judicial review

May 2015

The Health Research Authority (HRA) authorises trials and works to ensure the safety of patients taking part. It has proposed that all drug trials in future must be registered because in the past drug companies have been able to hide bad results by not publishing them. This can then result in a drug appearing to work better and more safely than it actually does.

The HRA proposals have also included a requirement on those running trials to ensure that all previous studies in which they were involved have also been registered. This is to try to bring historical information to light that perhaps has never been published. Our longstanding readers will remember our campaign to maintain animal insulin and may also remember that one of the problems was that we did not have full access to the trials of the then new ‘human’ insulin. So we were unable to demonstrate from research that some people did have adverse reactions to ‘human’ insulin as their strong anecdotal evidence suggested.

AllTrials Campaign

A campaign for transparency in human drug trials was launched in 2013 – the AllTrials campaign. One of the organisations behind this is Sense About Science but the campaign in favour of the HRA’s proposals has been supported by many researchers including the Cochrane Collaboration, the Wellcome Trust and the Medical Research Council as well as the public, patients, doctors and pharmacists. If patients have been willing to take part in research, then they deserve to have the findings published whether these results are negative or positive or put another way, whether the results are to the liking of the drug companies or not.

Another advantage of registering all trials is that it would prevent scientists from repeating a trial that may have failed and not been published, as well as giving them important information if they are trying to develop new treatments.

The battle for greater transparency in human drug trials has faced a serious setback with a legal challenge. Richmond Pharmacology, a company that conducts clinical trials on behalf of major drug companies has received permission to bring a judicial review of the HRA’s proposals. If the decision of the judicial review goes against the HRA, the drug companies will be able to continue their secrecy in clinical trials.

At the time of writing, the HRA is preparing its defence and has confirmed that it will continue to act in line with its statutory duties to protect and promote the interests of patients and the public in health research.